The Food and Drug Administration is sending mixed messages regarding the recent release of final guidance stating that it does not intend to enforce compliance with regulatory controls for medical device data systems (MDDS) and whether product manufacturers should in fact comply.
MDDS is hardware or software that transfers, stores, converts formats, and displays medical device data from a variety of other devices, including glucose meters, blood pressure cuffs, and weight scales. Last month, the FDA announced its intention not to enforce compliance with the regulatory requirements that apply to MDDS, including registration and listing, premarket review, postmarket reporting, and quality system regulation for manufacturers of these types of devices.
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